What have you been reading, hearing or TV viewing that has provoked some feelings of comfort or concern about what is happening in the world of medicine, medical care, treatment or science? Ethics is all about doing the right thing. Are you aware of any issues in medicine or biologic science which are being done right, could be improved or in fact represent totally unethical behavior?
Write about them here.. and I will too! ..Maurice (DoktorMo@aol.com)

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Sunday, December 02, 2007

Science at Any Cost?:The Ethics of the Use of Unethically Derived But Valid Experimental Data

I think that the title of my blog thread "Science at Any Cost?:The Ethics of the Use of Unethically Derived But Valid Experimental Data" tells it all. But what is the answer? History provides examples of such experiments both in Nazi Germany and other parts of the world and in earlier years even within the United States.

Martin T Donohoe, MD, FACP, a physician-ethicist, wrote the following scenario and a series of questions to a bioethics listserv which challenges the reader to think out what would be ethical responses to the questions. Martin has given me permission to post his scenario and questions here. I am sure that we both would be interested in reading my visitors responses. ..Maurice.

You are editor of a highly prestigious, well-read medical journal. A paper is submitted from "investigators" living in a country with a horrible human rights record. The investigators deliberately gave 100 women breast cancer, and waited for metastases to form. They then used a new treatment, first tested in animals, in a placebo-controlled trial wherein 50 women received placebo and 50 received the new treatment. Only 5 of the placebo-treated patients survived after 3 years, whereas 45 of the drug-treated women survived and were confirmed disease-free. Record keeping was excellent, all scans/lab reports, path slides, etc have been submitted, and the data appear solid.

Would you publish the results? If so, would you publish them with an editorial saying how bad this is?

Would you make the information available to the press but not publish the data?

What if that led to enormous profits for these "investigators'" clinic consequent to clinical visits, esp from desperate yet wealthy patients? (Assume the government would have no interest in cracking down on these "scientists," possibly because they could skim off the top of the enormous amounts of money that could be made)

If not, would you use the information if you or your wife or mother had breast cancer, if you could procure the drug in question?

Would it make any difference if the women in the study freely consented? Were paid an amount equal, say, to 10 times their potential lifetime earnings?

5 Comments:

What would a doctor in this situation do if the have this highly unethically obtained information, but yet they are treating several women who aren't responding to normal treatments and this information indicates that they would probably all be helped, and probably cured?

This then becomes a situation where no matter what you do, it can be viewed as a being questionable. If you can help them, and you don't, that would be hard to live with.

mj kc, you know.. I was thinking also about another scenario in which an observant Catholic or any "right to life" patient a few years from now who had Parkinsonism which was severe and debilitating and not responding to any common drug treatments available, had the opportunity to be treated with stem cells and to be relieved of many of the symptoms. However, this stem cell treatment came directly out of the research with embryonic stem cells obtained from discarded embryos. Would that Catholic patient accept the stem cell treatment even if by then the cells actually were derived from the patient's own skin cells..but,the original experiments,establishing the technique, were only from embryo sources? How is that for a personal dilemma? What if that patient (and I don't wish bad luck on anyone) was former President George W. Bush or even one of his daughters? ..Maurice.

There appear to be some ethical dilemmas where there simply may not be a totally correct response. No matter what is decided, it is likely to be a stressful decision that may not be 100% supportable. Sometimes you just have to deal with things the best that you can and understand that there is no right answer to every situation.

The original situation is particularly bad because if you use the information you could be sending a message to other researchers to do something similar and just as unethical.

I understand that one way of solving the dilemma regarding the use of a product developed under alleged immoral/unethical methods is to consider the distance one is from the origin of the immoral acts. I know this argument has been used to allow such use. It is interesting to read the commentary titled "Religious Conscience and Aborted Fetal Vaccine-A Catholic Prerogative" by the Children of God for Life debating that explanation with regard to the use of aborted embryonic tissue for vaccine production. Does anyone think that the rationale of distance is a valid one in any situation where immoral or illegal act has occurred? ..Maurice.

Excerpt from Children of God for Life: There has been much published material about whether the use of the vaccines derived from these fetal lines constitutes complicity in the evil of abortion. Some have argued the cooperation is slight, some have argued it is mediate, while still others have argued there is no cooperation at all. However, previous writings from most ethicists have concluded the use of the vaccines to be one of “remote material cooperation.” It is not our intention here to debate whether the use of these vaccines is indeed remote cooperation or perhaps a bit more intimate in light of the evidence already presented, but rather to address the problems created by these theories for Catholics.

To begin with, none of the ethicists using this argument have ever stated that remote material cooperation is not sinful. In fact, what the USCCB Pro-Life Secretariat office has stated is:

“If such collaboration with abortion has already taken place, and the only vaccine made available for serious diseases contains material that was cultured in fetal tissue from an abortion, may Catholics -- out of concern for their own health or that of their children or the community – submit to this vaccine without committing serious sin? Most Catholic moralists have replied in the affirmative.”

Therein is the crux of the problem. For if it is not sinful at all to use the vaccines, why not just come right out and say so? Instead, the conclusion was that it is not “serious sin”, leaving one to draw the conclusion then that it may be somewhat sinful. If so, most faithful Catholics would most certainly want to avoid anything that was sinful in nature, even if it is only venial.

But defining various levels of cooperation can become quite complicated. In their June 2005 statement, the Vatican defined three categories of people who cooperate with evil to some degree on the tainted vaccines:1) Those who prepare the vaccines2) Those who participate in their mass marketing3) Those who use the vaccines

They then laid down the varying levels of cooperation with evil by linking the above three types of persons with three ways cooperation is accomplished, each lessening in severity numerically: 1) The complicity with abortion 2) Complicity with marketing of cells from abortion3) Complicity with marketing of the vaccines

Beginning with the least guilty parties, rightfully, the Vatican concluded that a patient or parent who uses the vaccines only cooperates slightly with the abortion. However the degree of cooperation is more intimate with the marketing of cells, tissues and ultimately even closer with the actual use of the tainted vaccines. Likewise, the Vatican concluded that authorities and health systems bear a “more intense” cooperation than did the vaccine users.

The pharmaceutical companies, however, that were directly involved and both market and utilize the aborted fetal cell lines are guilty of formal material cooperation, which is morally illicit. In fact, their level of complicity when they participate with full knowledge is equal to that of the abortionists. When examining the degrees of moral culpability in an act of evil on one end of the ethics spectrum is “formal cooperation” which is always serious, and therefore a mortal sin. On the other end is “complete disassociation” which would not be considered sinful at all. In that the parents and medical professionals fall somewhere between these two points in varying degrees, leads one to conclude there is some sort of sinfulness associated with using the vaccines. That in itself, is a serious problem for faithful Catholics.

As Fr. Stephen Torraco noted:“For society, or even worse, for the Church, to argue that access to the vaccines is without moral problems is not only false, but also a failure on the part of both society and the Church to argue that society has the moral obligation to come up with alternatives to these vaccines.”

I think, under the original circumstances, the best course of action would be to instigate disciplinary procedures against the authors concerned to ensure they never practiced medical research again, and hopefully rotted in a jail cell for the rest of their lives. This should be done (and it feels weird to be saying, this, but I think to avoid a copycat syndrome, it's necessary) as quietly as possible.

The results should be released to the medical fraternity but anonymously so that the authors get no credit, and the drug should be made available at cost price internationally so that no pharmaceutical company who sponsored the research, wittingly or no, should gain anything by it.

I am aware that what I suggest is a logistical nightmare, but I think ethically it is possibly the best course of action.

On the stem cell question, anecdotally, I have a friend who is a devout christian (opposed to abortion) with a spinal injury. When I asked him exactly that question, he replied that he would probably take drugs derived from stem cell research (and be uncomfortable about it), but not those made from stem cells.

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